Voluntary Harmonisation Procedure (VHP)
Harmonized authorisation by competent authorities of clinical trials in two or more EU member states after submission of a single application file (VHP)
Since December 2014, a new modified Voluntary Harmonisation Procedure (VHP) Guideline version 3.2 for all clinical trials of medicinal products can be used. A single application submitted to the Clinical Trials Facilitation Group (CTFG) in English will be evaluated in a single procedure together by the competent authorities of those Member States where the clinical trial will be carried out. A single NCA will take over the duty of a Reference NCA (Rapporteur). The sponsor of a CTA is required to propose one of the participating NCAs as a Ref-NCA. This proposal is not binding for the MS. In the case of no Ref-NCA in spite of the Sponsor proposal and internal selection mechanisms at the end of the validation phase, a VHP will not be performed (see Guidance Document for more details). After the successful process of finding a Ref-NCAs scientific questions on the protocol and the investigational medicinal product will thus be clarified together. Subsequently, the clinical trial authorisation by each competent involved will be generally provided within 10 days.
The main criteria and improvements of the new procedure are:
- The clinical trial is planned to be carried out in two or more Members States.
- A Second Round/wave for the inclusion of new Member States after a VHP under defined conditions are introduced
- Subsequent substantial amendments will also be handled by the VHP.
- Rules for conditions after a VHP or a VHP-substantial amendment as well as on potential fees have been clarified.
- The harmonized scientific assessment will start immediately following submission of a single application (written in English).
- The proposal of a Ref-NCA by the sponsor is mandatory
- Changes of the list of participating Member States and responsibilities
- Introduction of participation of Ethics Committees for some participating Member states (VHP-Plus)
The participation of Ethics Committees is possible for some participating member states. Inclusion of Ethics Committees is only possible for initial applications.
A direct contact between Ethisc Committees and applicant is neither foreseen nor necessary in VHP.
For Germany applicants are invited to contact the VHP administrator for details if they are interested to involve Ethics Committees in a VHP. This involves only the assessment of the benefit/risk, investigators brochure and study protocol in the VHP and no other documents.
Phone: +49 6103 771810